Vanderbilt Clinical Trials

Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections

Purpose

This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).

Conditions

Pulmonary Invasive Fungal Infections
Pulmonary Invasive Aspergillosis

Eligibility

Eligible Ages: Between 120 Days and 21 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Males or females age > 120 days and < 22 years at any participating site - Have at least one of the following conditions associated with a known high incidence of IFI: hematopoietic stem cell transplantation (HSCT), aplastic anemia, bone marrow failure, primary or acquired immune deficiency, or malignancy - New (last 96 hours) radiographic evidence of at least one of the following: at least one nodular lesion greater than or equal to 5 mm in size, a wedge-shaped and segmental or lobar consolidation, a cavitary lesion, a lesion with a halo sign, a lesion with a reverse halo sign, or a lesion with an air crescent sign - Prolonged neutropenia (absolute neutrophil count < 500 cells/µl for a period of ≥ 5 consecutive days) in 30 days prior to and including the day of qualifying chest MRI or CT scan date OR currently receiving systemic therapy for acute or chronic graft-versus-host disease (GVHD) OR presence of neutrophil dysfunction because of underlying acquired or primary immune deficiency (e.g. chronic granulomatous disease) on the date of the qualifying chest MRI or CT scan - Subject consent or parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria

Weight <3 kg, so as to not exceed 3 ml/kg in a single blood draw - Previous inclusion in this study

Study Design

Phase
Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
Patients with possible PIFI		Diagnostic Test: Non-Invasive Testing for PIFI galactomannan assay, fungal PCRs, cell-free next-generation DNA/RNA sequencing, RNAseq

Recruiting Locations

Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232

More Details

Status: Recruiting
Sponsor: Arkansas Children's Hospital Research Institute

Study Contact

PFN Central Coordinator
501-364-3057
PFNClinical@uams.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.